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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02019264




Registration number
NCT02019264
Ethics application status
Date submitted
18/12/2013
Date registered
24/12/2013
Date last updated
16/07/2019

Titles & IDs
Public title
A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors
Secondary ID [1] 0 0
2013-000324-34
Secondary ID [2] 0 0
APD356-G000-401
Universal Trial Number (UTN)
Trial acronym
CAMELLIA-TIMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
High Cardiovascular Risk 0 0
Obesity 0 0
Overweight 0 0
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lorcaserin hydrochloride
Treatment: Drugs - Placebo

Experimental: Lorcaserin hydrochloride (HCL)10 mg - APD356 10 mg twice daily

Placebo Comparator: Placebo - Placebo twice daily


Treatment: Drugs: Lorcaserin hydrochloride
APD356 10 mg twice daily

Treatment: Drugs: Placebo
Placebo twice daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis - The MACE events involved myocardial infarction (MI), stroke, or cardiovascular (CV) death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Timepoint [1] 0 0
Baseline up to Month 42
Primary outcome [2] 0 0
Time From Randomization to First Occurrence of MACE+ - The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or heart failure (HF), or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Timepoint [2] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [1] 0 0
Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Participants With Prediabetes at Baseline - Time from randomization to conversion to T2DM was defined as first occurrence of any component of the 2013 American Diabetes Association (ADA) Diagnostic Criteria (ADA, 2013) in participants with prediabetes at baseline. The diagnostic criteria were met if a participant had unequivocal hyperglycemia (random plasma glucose greater than or equal to (>=) 200 milligram per deciliter (mg/dL) (11.1 millimole per liter [mmol/L]) with classic symptoms of hyperglycemia or hyperglycemic crisis) or any of the following criteria were observed and subsequently confirmed on repeat laboratory testing such as: glycosylated hemoglobin (HbA1c) >=to 6.5%; fasting plasma glucose (FPG) >=126 mg/dL (7.0 mmol/L); 2-hour plasma glucose >=200 mg/dL (11.1 mmol/L) by an oral glucose tolerance test (OGTT). The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Timepoint [1] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [2] 0 0
Time From Randomization to First Occurrence of the Individual Components of MACE+ - The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or HF, or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Timepoint [2] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [3] 0 0
Time From Randomization to Event of All-cause Mortality - The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Timepoint [3] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [4] 0 0
Time From Randomization to Conversion to Normal Glucose Homeostasis in Participants With Prediabetes at Baseline - Normal glucose homeostasis was defined as HbA1c less than or equal to (<=) 5.6% and FPG < 100 mg/dL without any antidiabetic treatment. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Timepoint [4] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [5] 0 0
Time From Randomization to Conversion to T2DM for Participants Without Any Type of Diabetes at Baseline - The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Timepoint [5] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [6] 0 0
Change From Baseline in HbA1c at Month 6 in Participants With T2DM at Baseline
Timepoint [6] 0 0
Baseline, and Month 6
Secondary outcome [7] 0 0
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Participants - New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (albumin-to-creatinine ratio [ACR] >=30mcg/mg and ACR>=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at Baseline developed macroalbuminuria, ACR increased >=30% from Baseline during treatment), newly developed chronic kidney disease (CKD) (eGFR >=90 milliliter per minute per 1.73 [mL/min/1.73]body surface area (BSA) and without kidney damage at Baseline changed to CKD Stage 1/higher as per National Kidney Foundation [NKF] Guidelines [2002]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines [2002] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times Baseline value and >=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Timepoint [7] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [8] 0 0
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With Prediabetes at Baseline - New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (ACR >=30mcg/mg and ACR >=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at baseline developed macroalbuminuria, ACR increased >=30% from baseline during treatment), CKD (eGFR >=90 mL/min/1.73 BSA and without kidney damage at baseline changed to CKD Stage 1/higher as per NKF Guidelines [2002]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines [2002] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times baseline value and >=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Timepoint [8] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [9] 0 0
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With T2DM at Baseline - New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (ACR >=30 mcg/mg and ACR >=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at baseline developed macroalbuminuria, ACR increased >=30% from baseline during treatment), CKD (eGFR >=90 mL/min/1.73 BSA and without kidney damage at baseline changed to CKD Stage 1/higher as per NKF Guidelines [2002]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines [2002] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times baseline value and >=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Timepoint [9] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [10] 0 0
Time From Randomization to Event of Improvement in Renal Function in Participants With T2DM at Baseline - Improvement in renal function was defined as first occurrence of regression of albuminuria or regression of CKD. Regression of albuminuria was defined as when participants with macroalbuminuria at baseline developed microalbuminuria or nonalbuminuria (ACR <30 mcg/mg in spot urine), or participants with microalbuminuria at baseline became nonalbuminuric, and ACR value decreased >= 30% from previous assessment during treatment. Regression of CKD defined as when participants with CKD Stage 1 or higher at baseline improved to normal or lower stages by NKF guidelines (eGFR >=90 with albuminuria at baseline improved to eGFR >=90 without albuminuria, or eGFR 60 to 89 at baseline became eGFR >=90 with or without albuminuria, or eGFR between 30 to 59 at baseline improved to >60 mL/min/1.73 BSA) during treatment. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Timepoint [10] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [11] 0 0
Percentage of Participants Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes
Timepoint [11] 0 0
Months 6 and 12
Secondary outcome [12] 0 0
Percentage of Participants With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy
Timepoint [12] 0 0
Months 6 and 12
Secondary outcome [13] 0 0
Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure
Timepoint [13] 0 0
Baseline, Month 12

Eligibility
Key inclusion criteria
Inclusion Criteria

1. BMI greater than or equal (>=) to 27 kilogram per meter square (kg/m^2)

2. Subjects able and willing to comply with a reduced-calorie diet and an increased
physical activity program

3. Age >= to 40 years with established CV disease as defined by one of the following:

1. History of documented MI or ischemic stroke

2. History of peripheral artery disease

3. History of revascularization (coronary, carotid, or peripheral artery)

4. Significant unrevascularized coronary arterial stenosis

OR

Age >= to 55 years for women or >= to 50 years for men who have type 2 diabetes mellitus
(T2DM) without established CV disease plus at least one of the following CV risk factors:

1. Hypertension, or currently receiving therapy for documented hypertension

2. Dyslipidemia, or currently taking prescription lipid-lowering therapy for documented
dyslipidemia

3. Estimated glomerular filtration rate >= to 30 to less than equal (<=) to 60 mililitre
per minute per 1.73 meter square (mL/min/1.73 m^) per the Chronic Kidney Disease
Epidemiology Collaboration (CKD-EPI) equation

4. High high sensitivity C-reactive protein (hsCRP)

5. Urinary albumin-to-creatinine ratio (ACR) >= 30 ug/mg

Subjects with T2DM may have a pre-existing or new diagnosis of T2DM. A new diagnosis of
T2DM (ie, discovered at Screening) should be based on the 2013 American Diabetes
Association (ADA) guidelines.

All T2DM subjects must have an HbA[1c] less (<) than 10% at Screening. If subjects are
being treated, or upon diagnosis need to be treated with antidiabetic agents, the T2DM
treatment regimen must be stable for at least 3 months prior to randomization.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Moderate or greater symptoms of congestive cardiac failure (New York Heart Association
[NYHA] class III or IV)

2. Known left ventricular (LV) ejection fraction < than 20%

3. Moderate or greater symptoms of pulmonary hypertension (PH)

4. Known severe valvular disease

5. Moderate renal impairment, severe renal impairment (estimated glomerular filtration
rate < 30 mL/min/1.73 m^ per the CKD-EPI equation based on ideal body weight), or end
stage renal disease (ESRD)

6. Severe hepatic impairment

7. Use of other products intended for weight loss including prescription drugs,
over-the-counter (OTC) drugs, and herbal preparations

8. Use of more than one other serotonergic drug

9. Use of drugs known to increase the risk for cardiac valvulopathy within 6 months prior
to Screening including, but not limited to: pergolide, ergotamine, methysergide,
cabergoline

10. History or evidence of clinically significant disease (e.g., malignancy, cardiac,
respiratory, gastrointestinal, renal or psychiatric disease)

11. Use of lorcaserin HCl prior to Screening or hypersensitivity to lorcaserin HCl or any
of the excipients

12. Planned bariatric surgery

13. Females must not be breastfeeding or pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [2] 0 0
Gosford Hospital, Cardiology Clinical Trials - Gosford
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
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Illawarra Shoalhaven Local Health District, Clinical Trial and Research Unit - Wollongong
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Wollongong Hospital - Wollongong
Recruitment hospital [6] 0 0
Core Research Group - Brisbane
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Princess Alexandra Hospital, Cardiology Research Department - Brisbane
Recruitment hospital [8] 0 0
Royal Brisbane and Women's Hospital, Endocrinology Department - Herston
Recruitment hospital [9] 0 0
HeartCare Partners Clinical Research Unit - Milton
Recruitment hospital [10] 0 0
AusTrials Pty Ltd - Sherwood
Recruitment hospital [11] 0 0
Gold Coast Hospital, Cardiovascular Research Centre - Southport
Recruitment hospital [12] 0 0
New Royal Adelaide Hospital, Cardiology Department - Adelaide
Recruitment hospital [13] 0 0
Adelaide Medical Research - Ashford
Recruitment hospital [14] 0 0
Lyell McEwin Hospital, Department of Cardiology - Elizabeth Vale
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Heart and Vascular Institute - Fullarton
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The Queen Elizabeth Hospital - Woodville South
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Ballarat Health Services - Ballarat
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Geelong Cardiology Research Unit, Barwon Health - Geelong
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Austin Health - Heidelberg Repatriation Hospital, Department of Medicine, Boronia Centre - Heidelberg Heights
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Avenue Cardiovascular Centre - Saint Kilda East
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Joondalup Cardiovascular Trials Foundation Inc - Joondalup
Recruitment hospital [22] 0 0
Fiona Stanley Hospital, Cardiology Research Department,CDO11 - Murdoch
Recruitment hospital [23] 0 0
South Australian Medical Research Inst, Centre for Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
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2250 - Gosford
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2170 - Liverpool
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2500 - Wollongong
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4064 - Brisbane
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4102 - Brisbane
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4029 - Herston
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4064 - Milton
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4075 - Sherwood
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4215 - Southport
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5000 - Adelaide
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5035 - Ashford
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5112 - Elizabeth Vale
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SA 5063 - Fullarton
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5011 - Woodville South
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3353 - Ballarat
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3220 - Geelong
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3081 - Heidelberg Heights
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3183 - Saint Kilda East
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6027 - Joondalup
Recruitment postcode(s) [21] 0 0
6150 - Murdoch
Recruitment outside Australia
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Bialystok
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Gdynia
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Legnica
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Lublin
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Tarnów
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Torun
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Warszawa
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Wierzchoslawice
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Wroclaw
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Wloclawek
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Lódz
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Leczna

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eisai Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Thrombolysis In Myocardial Infarction (TIMI) Academic Research Organization
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in
overweight and obese subjects with cardiovascular (CV) disease and/or multiple CV risk
factors.
Trial website
https://clinicaltrials.gov/show/NCT02019264
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications